FDA Inspections in 2021 for Drug and Device Manufacturers

FDA suspended most field inspections of drug and device facilities in March 2020 due to the COVID-19 pandemic. Although rare, mission-critical inspections have continued, and Medical Device Single Audit Program (MDSAP) inspections have continued virtually. FDA officials have said they will rely more heavily on inspection alternatives to ensure product safety, including review of a facility’s past compliance history, sampling of imported products at the border, and evaluation of inspection reports of trusted foreign regulatory authorities. For drugs, another alternative to inspection is for FDA to request documents “in advance of or in lieu of an inspection” under Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA has recognized, however, that it often is not feasible to rely on alternative tools, which “can be as resource intensive as inspections”—for FDA and industry alike. In December 2020, FDA acknowledged the impact of the inspection hiatus on facility assessments necessary for pending drug and biologics applications. In addition, Agency officials have expressed skepticism about using alternative approaches for follow-up inspections of firms with problematic inspectional histories, noting that many follow-up inspections have revealed that earlier problems persist. 

FDA inspections likely will resume sometime in 2021. Until then, we recommend that industry work to stay “audit ready” by conducting gap assessments and mock inspections, training specialized staff, and monitoring and correcting known deficiencies. This webinar will:

• Review FDA’s guidances and policy statements regarding manufacturing, supply chain and facility inspections during the COVID-19 pandemic.
• Provide recommendations for managing virtual audits and conformity assessments being conducted by Notified Bodies and MDSAP auditing organizations.
• Provide advice about managing requests for documents made under FD&C Act § 704(a)(4) and discuss how FDA is using the information obtained to plan future on-site inspections.
• Discuss potential alternatives to in-person inspections (e.g., Remote Regulatory Assessments) and whether and when they are viable for particular manufacturers.
• Recommend actions that drug and device manufacturers should be taking now, while most FDA inspections are suspended, to prepare for the day when audits resume in their regular form.

If you have questions concerning this roundtable webinar, email Chayako Williams at cbwilliams@kslaw.com.

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